Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Autoimmune Reagent Kit, Cardiolipin Screen
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030402891
- Basic UDI-DI Code
- B-06924030402891
- Reference
- MY00174
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- HOB Biotech Group Corp., Ltd.
Additional Description
The BioCLIA Autoimmune Reagent Kit, Cardiolipin Screen assay is intended for the in vitro semi-quantitative measurement of anti-Cardiolipin IgA/IgG/IgM antibodies in human serum and plasma as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders in conjunction with other laboratory and clinical findings. It is an in vitro diagnostic medical device intended for laboratory professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100501 | ANTI-CARDIOLIPIN ANTIBODIES |
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